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Home » New Siemens antibody test can help quantify level of immune response to COVID-19

New Siemens antibody test can help quantify level of immune response to COVID-19

August 4, 2020 By Chris Newmarker

Siemens HealthineersSiemens Healthineers (ETR: SHL) today announced that it’s secured an FDA emergency use authorization for its SARS-CoV-2 IgG (COV2G) antibody test, which the company touts as the first authorized with semi-quantitative detection.

The COV2G test not only provides positive or negative result for IgG antibodies but also reports a numerical result expressed as index value — helping clinicians to gauge the level of IgG antibodies in a patient’s blood sample. The idea is that the test will help clinicians better understand how people’s immune response changes over time after exposure to the virus that causes COVID-19.

The test has also attained the CE Mark in the European Union and is now broadly available globally. The test, according to Siemens, has b sensitivity and specificity that is greater than 99%.

“Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” Deepak Nath, president of Laboratory Diagnostics for Siemens Healthineers, said in a news release.

This is the fifth Siemens Healthineers antibody test for COVID-19 to receive an FDA EU since the pandemic began.

“Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19,” Nath said.

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, Siemens Healthineers

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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